To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes.
Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019
This bill (1) reauthorizes, revises, and establishes several programs and entities relating to public-health emergency preparedness and response; and (2) addresses the approval process for over-the counter (OTC) drugs.
Among other programs, the bill reauthorizes through FY2023 and revises
In addition, the bill provides statutory authority for existing programs, including the CDC's Children's Preparedness Unit and the Public Health Emergency Medical Countermeasures Enterprise. The bill also establishes new programs and entities, including a trauma-center grant program to support military trauma teams.
The bill further modifies the approval process for OTC drugs by providing statutory authority for the Food and Drug Administration (FDA) to (1) regulate certain OTC drugs that are marketed without an approved new-drug application, and (2) issue administrative orders specifying the conditions under which an OTC drug may be deemed safe and effective and not subject to approval as a new drug. The FDA must assess and collect user fees for OTC drugs, including OTC-drug facility and OTC-drug order-request fees.
Referred to the Subcommittee on Health.
Sponsor introductory remarks on measure. (CR E971)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Became Public Law No: 116-22.
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Homeland Security, Veterans' Affairs, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Homeland Security, Veterans' Affairs, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Homeland Security, Veterans' Affairs, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Homeland Security, Veterans' Affairs, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Mr. Pallone moved to suspend the rules and pass the bill.
Considered under suspension of the rules. (consideration: CR H237-266)
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Referred to the Subcommittee on Health.
DEBATE - The House proceeded with forty minutes of debate on H.R. 269.
At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
Considered as unfinished business. (consideration: CR H275-276)
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 401 - 17 (Roll no. 13).(text: CR H237-262)
Roll Call #13 (House)On motion to suspend the rules and pass the bill Agreed to by the Yeas and Nays: (2/3 required): 401 - 17 (Roll no. 13). (text: CR H237-262)
Roll Call #13 (House)Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.
Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 10.